Contour next GEN Blood Glucose Monitoring System

FDA device recall Z-2211-2023 · posted 2023-07-20 · Open, Classified

Recall details

Recalling firm

Ascensia Diabetes Care US, Inc.

Reason for recall

Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.

Action taken

The firm sent recall notifications to customers dated 06/21/2023. Customers are asked to check their personal meters and entities are asked to check their stock to identify any affected devices. If you are aware of any patients or customers downstream who have received a recalled device make them aware of this recall. Anyone with a recalled unit can contact the firm at 1-800-348-8100 or by email at support@contournext.com to initiate return and replacement of devices. Response Forms were provided for customers to return via email to qualitysupport@ascensia.com.

Root cause

Process control

Status

Open, Classified

Product code

NBW

Quantity affected

2,888 units

Distribution

Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.

Date initiated

2023-05-19

Date posted

2023-07-20

Location

Valhalla, NY

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